BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 15808173 · Received November 16, 2022

    Report

    Report Number
    2210968-2022-09503
    Event Type
    Injury
    Date Received
    November 16, 2022
    Date of Event
    March 7, 2022
    Report Date
    November 30, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-09502, 2210968-2022-09504. CITATION: GRAEFE'S ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY (2022) 260:2991¿3000. HTTPS://DOI.ORG/10.1007/S00417-022-05612-X.

    Description of Event or Problem · 0

    TITLE: A COMPARISON OF LONG-TERM RESULTS AFTER BAERVELDT 250 IMPLANTATION IN ADVANCED UVEITIC VS. OTHER FORMS OF GLAUCOMA. THE AIM OF THIS STUDY IS TO EVALUATE THE LONG-TERM EFFICIENCY AND SAFETY FOLLOWING BI-250 IN COMPLEX EYES SUFFERING FROM GLAUCOMA DUE TO UVEITIS (UG) VS. OTHER FORMS (OFG). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED AT THE EYE CENTER OF THE MEDICAL CENTER, UNIVERSITY OF FREIBURG. ALL PATIENTS THAT UNDERWENT A BI-250 BETWEEN 2013 AND 2019 WERE IDENTIFIED. THEIR LAST PRE-OPERATIVE AND ALL FOLLOW-UP MEDICAL RECORDS WERE REVIEWED. PATENCY WAS ENSURED THROUGH IRRIGATION, AND TUBE OCCLUSION WAS PERFORMED USING A VICRYL RAPIDE 6¿0 SUTURE IN ORDER TO PREVENT POST-OPERATIVE HYPOTONY. THE TUBE WAS ATTACHED TO THE GLOBE USING NYLON 10¿0 SUTURES AND THE SCLERAL FLAP WAS SECURED AND CONJUNCTIVA CLOSED USING VICRYL 7¿0 SUTURES. REPORTED COMPLICATIONS INCLUDED INFLAMMATION (N=4), TREATMENT: NOT REPORTED. PERSISTENT HYPERTENSION CAUSED BY A FIBROTIC MEMBRANE AND AN UNABSORBED TUBE SUTURE. TREATMENT: REQUIRED SURGICAL/LASER INTERVENTIONS. EXPULSIVE HEMORRHAGE. TREATMENT : NOT REPORTED. DIPLOPIA. TREATMENT : NOT REPORTED.. RETINAL DETACHMENT. TREATMENT: TREATMENT : NOT REPORTED. IN CONCLUSION THE BAERVELDT 250 IMPLANT IS SHOWN TO BE BOTH EFFECTIVE AND SAFE FOR ADVANCED GLAUCOMA CASES IN UVEITIS AND OTHER FORMS. NO FURTHER GLAUCOMA-RELATED SURGERY IS REQUIRED IN THE MAJORITY OF EYES IN EITHER GROUP WITHIN A FOLLOW-UP PERIOD OF ALMOST 2 YEARS. DESPITE SIGHT-THREATENING COMPLICATIONS SUCH AS MACULAR AND CORNEAL EDEMA, VISUAL ACUITY CAN BE EITHER MAINTAINED OR IMPROVED IN MOST EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416197 NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention